Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects

NCT01595425 | Completed Phase 1

• 1 other identifier: D961TC00001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

Conditions

Bioequivalence Study

Keywords

Bioequivalence,; pharmacokinetics,; safety,; esomeprazole,; Japanese,; healthy subject,; homo-EM

Outcome Measures

Primary Outcomes (1)

• AUCτ and Cmax,ss of D961H

  * AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration * Cmax,ss - maximum concentration at steady state

  Day 5

Secondary Outcomes (3)

• Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.

  Day 5

• Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.

  Up to 5 to 7 days after the last dose.

• Number of participants with adverse events.

  Up to 5 to 7 days after the last dose.

Study Arms (2)

D961H Sachet 20 mg

EXPERIMENTAL

2 way crossover

Drug: D961H Sachet 20 mg

D961HHPMC Capsule 20 mg

EXPERIMENTAL

2 way crossover

Drug: D961H HPMC capsule 20 mg

Interventions

D961H Sachet 20 mg DRUG

Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.

Also known as: esomeprazole sachet

D961H Sachet 20 mg

D961H HPMC capsule 20 mg DRUG

Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Also known as: esomeprazole, capsule 20 mg

D961HHPMC Capsule 20 mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Japanese healthy male subjects aged 20 to 45 years of age
• Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
• Clinically normal findings
• Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

You may not qualify if:

• Significant clinical illness
• Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
• Clinical significant condition which could modify the absorption of the investigational product
• Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Unit

Fukuoka, Fukuoka, Japan

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Masataka Date

  AstraZeneca R&D Japan

  STUDY DIRECTOR

• Masanari Shiramoto

  Hakata Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

JP (1)